BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGB

    MDR report key: 2894736 · Received December 5, 2012

    Report

    Report Number
    2894736
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 18, 2012
    Report Date
    December 5, 2012
    Manufacturer
    TELEFLEX, INC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    I HAD SOME RESISTANCE PUTTING IN THE GUIDEWIRE, BUT THEN AFTER GENTLE REDIRECTING, IT WENT IN EASILY. WHEN I TRIED PUTTING THE CATHETER OVER THE GUIDEWIRE, I HAD RESISTANCE FROM THE GET-GO, LONG BEFORE I GOT TO SKIN. I FIGURED THIS WAS FROM CLOTTING BECAUSE I COULDN'T THINK OF A GOOD REASON THE CATHETER WOULDN'T EASILY GO OVER THE GUIDEWIRE. I EVENTUALLY GOT THE CATHETER TO GLIDE OVER, AND IT WENT THROUGH THE SKIN EASILY. HOWEVER, PULLING THE GUIDEWIRE WAS DIFFICULT; THERE WAS SIGNIFICANT RESISTANCE. I TUGGED HARDER, IT CAME OUT, AND KEPT COMING, BUT THEN IT SHREDDED INTO TWO PIECES AS IT WAS COMING OUT OF THE MIDDLE PORT. WHEN WE SAW THAT, WE STOPPED PULLING THE GUIDEWIRE, AND PULLED OUT THE CATHETER INSTEAD. WE NOTICED THAT THE SPRINGY COIL PART OF THE WIRE WAS SEPARATED FROM THE STRAIGHT WIRE PART. UPON CALLING INTERVENTIONAL RADIOLOGY (IR), WE WERE TOLD TO JUST PULL WHATEVER WAS LEFT INSIDE THE BODY (ALL I SAW WAS THE SPRINGY PART GOING INTO THE BODY), SO I PULLED, AND WITH MUCH RESISTANCE, THE COILED WIRE CAME OUT. OF NOTE, THE CXR BEFORE SHOWED THE WIRE, AND THE CXR AFTER SHOWED NO FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGB CENTRAL VENOUS LINE GUIDEWIRE DQO TELEFLEX, INC ASK4570PECL *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR